Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

NCT01549925 | Completed Results DMC

• 1 other identifier: HCI41380
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical Time

  To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

  at time of surgery, up to 10 minutes

Study Arms (2)

standard surgical resection

OTHER

standard surgical resection using clamps and surgical ligatures

Other: Standard Surgical resection

LIGASURE

ACTIVE COMPARATOR

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Device: LIGASURE

Interventions

Standard Surgical resection OTHER

standard surgical resection using clamps and surgical ligatures

standard surgical resection

LIGASURE DEVICE

resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years or older
• All patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants.
• Potential candidates must have signed an IRB-approved Informed Consent (University of Utah Informed consent if their surgery will be performed at the Huntsman Cancer Hospital, or Intermountain Health Care consent if the surgery is to be performed at LDSH or IMC.
• Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Intermountain Health Care

Salt Lake City, Utah, 84111, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Mark Wade
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

801-213-5746

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: January 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 28, 2016
• Results First Posted: January 28, 2016

Record last verified: 2015-12

Locations

US (2)